MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4.5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-4511
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 68 y/o male patient's right knee was revised due to instability.Patient was originally implanted with a 4.5 x 11mm ps insert.During revision, surgeon upsized poly to 15mm.Patient was last known to be in stable condition following the event.X-rays are unavailable.Devices are not retuning - hospital policy.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the reported revision due to instability cannot be conclusively determined; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Subluxation and dislocation are known risks, as outlined in the ifu.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4.5 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16852833
• Report Number: 1038671-2023-00879
• Device Sequence Number: 20745196
• Product Code: JWH
• UDI-Device Identifier: 10885862304544
• UDI-Public: 10885862304544
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2025
• Device Catalogue Number: 02-022-35-4511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN
• Patient Age: 68 YR
• Patient Sex: Male